Common use of Development Plan and Budget Clause in Contracts

Development Plan and Budget. 4.1. NeuroRx shall direct, design and implement the entire pathway for U.S. drug approval for the Product (the “Project”). 4.2. NeuroRx shall be the designated party to all contractual agreements related to the manufacture and marketing of the Product in the NeuroRx Territory with external service providers and the sole named entity on all invoices related to activities associated with the Project. If Relief now or in the future chooses a commercialization partner other than NeuroRx in the NeuroRx Territory pursuant to Section 8.11 hereof, NeuroRx will assign all contractual agreements and Regulatory Licenses to Relief’s chosen commercialization partner. 4.3. Relief shall be the designated party to all contractual agreements related to the manufacture and marketing of the Product outside the NeuroRx Territory with external service providers and the sole named entity on all invoices related to activities associated with the pathway for marketing approval for the Product outside NeuroRx Territory. 4.4. NeuroRx is responsible for ensuring that all activities undertaken under the Project (a) comply with the Development Plan, (b) do not exceed 30% of the budget contemplated by Relief’s Board of Directors on March 22, 2020 (as may be amended by the written agreement of Relief and NeuroRx) and (c) comply with all applicable laws. 4.5. Given that Relief is a 50% partner in Net Profits earned in the NeuroRx Territory, all individual employees paid in excess of $500,000 shall be reasonably acceptable to Relief, such agreement not to be unreasonably withheld or delayed. 4.6. The Parties recognize that the March 22, 2020 budget did not contemplate the costs that have been incurred for drug formulation, manufacture, CMC, stability, etc., which costs have been funded by Relief. 4.7. Material updates or changes to the Development Plan or the budget (i.e., increased costs in the aggregate which exceed 30%) for the Project shall be approved by Relief’s Board of Directors, which shall not be unreasonably withheld or delayed. 4.8. Each of NeuroRx and Relief shall refrain from contacting any representative of any service provider, supplier or vendor in the NeuroRx Territory, in the case of Relief, and in the Relief Territory, in the case of NeuroRx, engaged or otherwise involved in the Project (including any and all service providers, suppliers and vendors involved in the performance of clinical development activities associated with the Product) in a manner that is reasonably likely to have a material and adverse effect on the Project without providing the other Party with reasonable prior written notice and the opportunity to participate in discussions and negotiations therewith; provided that NeuroRx shall not be obligated to provide such advance notice or opportunity to participate to Relief solely to the extent such contact is imminently necessary to provide patient care and provided that NeuroRx provides notice to Relief of such contact immediately thereafter. 4.9. Revenues from grants, Priority Review Vouchers, or any other similar sources, shall be divided between the Parties as follows: in the NeuroRx Territory 50/50 and in the Relief Territory 85/15, and on an 80/20 basis in Relief’s favor in the ROW Countries.

Appears in 2 contracts

Sources: Binding Collaboration Agreement (Relief Therapeutics Holding SA), Binding Collaboration Agreement (Big Rock Partners Acquisition Corp.)